In the face of patient and physician hesitance about the safety and efficacy of biosimilars, long-known innovator company brands reassure stakeholders of the company’s experience, quality, and reliability. But this begs the question, how do smaller biosimilar companies fit in?
If you are considering whether to take the time in advance of your investigational new drug (IND) application submission to meet with FDA for feedback on your development program, here are some thoughts to ponder and reasons not to pass up this valuable opportunity.
Though there is already a vast amount of available biosimilar-related real-world evidence (or Big Data), the industry will face quite a few pitfalls in securing and interpreting this data.
Real-world evidence, or data from real-world practice and use outside of clinical trials during drug development, is steadily becoming a key complement to randomized clinical trials. As Quintiles' Nancy Dreyer said, “So far, we’ve been concentrating on how biosimilars are made and how they will affect patients. But we need to be thinking bigger.”
An ideology-driven rush to undo decades of healthcare policy — and the uncertainty this will create — presents real hazards for every segment of the U.S. healthcare system, including the pharmaceutical industry.
In the spirit of this list-making season, I compiled what I thought were the five most important biosimilar-related triumphs in the past year. Many of these events were widely covered by the media and will play an influential role in how the biosimilar industry unfolds through 2017 and beyond.
A few weeks ago, I sat in on a webinar hosted by ProCE called “Biosimilars Out Of The Gate: What Are the Latest Developments?” Though the webinar was not directly targeting companies developing biosimilars, I felt some of the insights carried important implications for biosimilar makers.
The first article in this series, Risk-Based Approaches To Establishing Sample Sizes For Process Validation (June 2016), provided and established the relationship between risk and sample size. This article will demonstrate the use of lot tolerance percent defective (LTPD) to establish sample sizes for process validation.
Now that the 21st Century Cures bill has been signed into law — following a nearly three- year journey that included a fair number of detours and roadblocks — all eyes in the drug development world are shifting to FDA. To the question “What now?” FDA can answer: A great deal of work.
Although change is constant, it generally comes very slowly to the highly regulated biopharma industry. Bringing a biologic to market can be a decades-long process, so tracking trends needs to take a long view. Based on decades of analysis, and findings from our 13th Annual Report of Biopharmaceutical Manufacturing, this article will outline some of the key factors affecting the industry today.
This application note describes how perfusion cell culturing can be used to reduce processing time, simplify operations, and maximize equipment utilization in seed culture expansion processes. For creation of high-density cell banks, Chinese hamster ovary (CHO) cells were expanded using a bioreactor system operated in perfusion mode.
The PDA Journal of Pharmaceutical Science and Technology, have taught us that using materials not intended for use with pharmaceuticals was not the best choice. The industry is now evolving toward developing single-use films better suited to fit the needs of biomanufacturing, specifically, end users that have communicated a need for improved film performance with reliable supply, which requires transparency along the entire supply chain.
Despite years of discussion and experience, E&L testing approaches for single-use equipment have not yet fully matured into a consensus industry practice. Copious amounts of data have been generated by the industry, but most of it is held under confidentiality. Trade organizations, such as the Bio-Process Systems Alliance (BPSA), of which GE is a member, and suppliers have derived their own approaches to testing. For end users who are adopting single-use (SU) equipment as a manufacturing strategy, this situation becomes unwieldy. The need for a standard approach both to the generation and to the reporting structure of extractables data becomes obvious.
As this shift to SUT continues, there is both an opportunity and an obligation to understand the sustainability impacts of that shift.
Single-use technologies offer an attractive option for biopharmaceutical manufacturing, but their environmental impact needs be considered.
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